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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K040653
Device Name PARAMOUNT MINI GPS BILIARY STENT SYSTEM
Applicant
Ev3, Inc.
4600 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact MARIA E BRITTLE
Correspondent
Ev3, Inc.
4600 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact MARIA E BRITTLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/12/2004
Decision Date 04/28/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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